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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K032524
Device Name ADVIA 60 HEMATOLOGY ANALYZER
Applicant
Bayer Healthcare, LLC
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact KENNETH T EDDS
Correspondent
Bayer Healthcare, LLC
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact KENNETH T EDDS
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received08/15/2003
Decision Date 09/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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